U.S. patent application number 15/726599 was filed with the patent office on 2018-02-22 for implantable drug eluting system and method of use.
The applicant listed for this patent is P Tech, LLC. Invention is credited to Peter M. Bonutti.
Application Number | 20180049743 15/726599 |
Document ID | / |
Family ID | 39188892 |
Filed Date | 2018-02-22 |
United States Patent
Application |
20180049743 |
Kind Code |
A1 |
Bonutti; Peter M. |
February 22, 2018 |
IMPLANTABLE DRUG ELUTING SYSTEM AND METHOD OF USE
Abstract
The present disclosure provides a system for injecting a drug
eluting construct in a patient. The construct includes multiple
cellular based microcaspules, wherein the multiple cellular based
microcapsules create at least one of a plurality of layers or
sections of microcapsules joined together to comprise an implant.
There is a medicinal agent within the microcapsules. A syringe and
needle inject the implant constructed of microcapsules into the
patient at least one of during and after a surgical procedure. The
medicinal agent controllably releases into the patient both
immediately and at a delayed time.
Inventors: |
Bonutti; Peter M.;
(Manalapan, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
P Tech, LLC |
Effingham |
IL |
US |
|
|
Family ID: |
39188892 |
Appl. No.: |
15/726599 |
Filed: |
October 6, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11842648 |
Aug 21, 2007 |
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15726599 |
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60822966 |
Aug 21, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/8847 20130101;
A61B 17/12136 20130101; A61B 17/72 20130101; A61F 2/38 20130101;
A61B 17/135 20130101; A61B 17/70 20130101; A61B 2018/0022 20130101;
A61L 31/145 20130101; A61B 17/12 20130101; A61B 2018/00023
20130101; A61K 35/24 20130101; A61K 31/715 20130101; A61L 31/045
20130101; A61P 43/00 20180101; A61L 2400/04 20130101; A61L 27/222
20130101; A61B 2017/00893 20130101; A61B 2018/00011 20130101; A61P
19/00 20180101; A61K 31/215 20130101; A61L 27/52 20130101; A61K
38/4833 20130101; A61B 2017/005 20130101; A61B 2017/12004 20130101;
A61B 18/14 20130101; A61F 2/44 20130101; A61B 17/1325 20130101;
A61P 17/02 20180101 |
International
Class: |
A61B 17/12 20060101
A61B017/12; A61L 31/04 20060101 A61L031/04; A61L 27/52 20060101
A61L027/52; A61L 27/22 20060101 A61L027/22; A61K 38/48 20060101
A61K038/48; A61K 35/24 20060101 A61K035/24; A61K 31/715 20060101
A61K031/715; A61K 31/215 20060101 A61K031/215 |
Claims
1. An implantable drug eluting construct for use in a patient, the
construct comprised of: multiple cellular based microcapsules,
wherein the multiple cellular based microcapsules form at least one
of a plurality of layers or sections of microcapsules joined
together to comprise an implant; and a medicinal agent positioned
within the microcapsules, wherein the medicinal agent is an
analgesic, and wherein the medicinal agent is controllably released
into the patient both immediately and at a delayed time after the
implant constructed of microcapsules is injected with a syringe and
needle into the knee joint of the patient at least one of during
and after a surgical procedure.
2. The construct of claim 1, wherein the analgesic is marcaine.
3. The construct of claim 1, wherein the analgesic is a neural
block.
4. The construct of claim 1, wherein the microcapsules are
biodegradable.
5. The construct of claim 1, wherein at least one of the
composition and dosage of the medicinal agent is different between
at least one of the layers or sections, and the medicinal agent is
released at varying rates.
6. An implantable drug eluting construct for use in a patient, the
construct comprised of: multiple cellular based microcapsules,
wherein the multiple cellular based microcapsules form at least one
of a plurality of layers or sections of microcapsules joined
together to comprise an implant; and a medicinal agent positioned
within the microcapsules, wherein the medicinal agent is an
anti-neoplastic and wherein the medicinal agent is controllably
released into the patient both immediately and at a delayed time
after the implant constructed of microcapsules is injected with a
syringe and needle into the spine of the patient.
7. The construct of claim 6, wherein the microcapsules are
biodegradable.
8. The construct of claim 6, wherein at least one of the
composition and dosage of the medicinal agent is different between
at least one of the layers or sections, and the medicinal agent is
released at varying rates.
9. A method for implanting a drug eluting construct in a patient,
the method comprising: forming multiple cellular based
microcapsules, wherein the multiple cellular based microcapsules
create at least one of a plurality of layers or sections of
microcapsules joined together to comprise an implant; positioning a
medicinal agent within the microcapsules; and injecting the implant
constructed of microcapsules with a syringe and needle into the
patient at least one of during and after a surgical procedure,
wherein the medicinal agent controllably releases into the patient
both immediately and at a delayed time.
10. The method of claim 9 wherein, the medicinal agent is an
analgesic.
11. The method of claim 10 wherein, the analgesic is marcaine.
12. The method of claim 10 wherein, the analgesic is a neural
block.
13. The method of claim 9, wherein the medicinal agent is an
anesthetic.
14. The method of claim 13, wherein the anesthetic is
lidocaine.
15. The method of claim 9, wherein the medicinal agent is an
anti-neoplastic
16. The method of claim 9, wherein the microcapsules are
biodegradable.
17. The system of claim 9, wherein the implant is a foam.
18. The method of claim 9, wherein at least one of the composition
and dosage of the medicinal agent is different between at least one
of the layers or sections, and the medicinal agent is released at
varying rates.
19. The method of claim 9, wherein the site of the injection in the
patient is at least one of the foot, ankle, hip, shoulder, elbow,
wrist, hand, knee, and spine.
20. A system for injecting a drug eluting construct in a patient,
the system comprising: multiple cellular based microcapsules,
wherein the multiple cellular based microcapsules create at least
one of a plurality of layers or sections of microcapsules joined
together to comprise an implant; a medicinal agent within the
microcapsules; and a syringe and needle, wherein the syringe and
needle inject the implant constructed of microcapsules into the
patient at least one of during and after a surgical procedure,
wherein the medicinal agent controllably releases into the patient
both immediately and at a delayed time.
21. The system of claim 20 wherein, the medicinal agent is an
analgesic.
22. The system of claim 21 wherein, the analgesic is marcaine.
23. The system of claim 21 wherein, the analgesic is a neural
block.
24. The system of claim 20, wherein the medicinal agent is an
anesthetic.
25. The system of claim 24, wherein the anesthetic is
lidocaine.
26. The system of claim 20, wherein the medicinal agent is an
anti-neoplastic
27. The system of claim 20, wherein the microcapsules are
biodegradable.
28. The system of claim 20, wherein the implant is a foam.
29. The system of claim 20, wherein at least one of the composition
and dosage of the medicinal agent is different between at least one
of the layers or sections, and the medicinal agent is released at
varying rates.
30. The system of claim 20, wherein the site of the injection in
the patient is at least one of the foot, ankle, hip, shoulder,
elbow, wrist, hand, knee, and spine.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. Non-Provisional
patent application Ser. No. 11/842,648, filed Aug. 21, 2007,
entitled METHOD OF INHIBITING THE FORMATION OF ADHESIONS AND SCAR
TISSUE AND REDUCING BLOOD LOSS, which claims the benefit of U.S.
Provisional Patent Application 60/822,966 to the same inventor,
filed Aug. 21, 2006, entitled METHOD OF INHIBITING THE FORMATION OF
ADHESIONS AND SCAR TISSUE, the entire contents of which are
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to a method of reducing blood
loss during surgery, while inhibiting the postoperative formation
of fibrosis, and more particular for inhibiting scar formation and
surgical adhesions, as well as decreasing exogenous bone
formation.
BACKGROUND OF THE INVENTION
[0003] The importance of reducing blood loss during surgery is well
understood. In the prior art, bandages are applied with pressure to
reduce bleeding, and cold is applied to reduce edema. To address
adhesion formation, barrier films are applied between abraded or
cut tissue.
[0004] Devices to cool postoperatively include the dental ice pack
of U.S. Pat. No. 6,217,606 to Portnoy et al., the dental compress
of U.S. Pat. No. 4,983,122 to Mitnick, and the fluid circulating
device of U.S. Pat. No. 5,190,032 to Zacoi. The dental devices
enclose a gel in a flexible envelope. The device is cooled and
positioned adjacent the surgical site postoperatively. The fluid
circulating device is intended to be more easily positioned
adjacent to the surgical site than prior art devices. While these
devices address postoperative blood loss and edema, as well as
patient comfort, they are not directed to blood loss during
surgery. More particularly, they are not adapted to be used during
surgery, as they would operate to entirely obscure the operating
field.
[0005] U.S. Pat. No. 3,867,939 to Moore discloses an absorbent
fluid circulating dressing or surgical sponge designed to be used
in an open wound. The device includes connections for a cold water
supply and return, and circulates the fluid between layers of
paper, scrim, and plastic film. While perhaps more compact than the
chemical cooling packs of the prior art, discussed therein, the
device none the less imposes considerable bulk in the context of
insertion into an active surgical field. In addition, there are
logistical problems of supplying cooled water, as well as having
available an adequate supply in the correct sizes. Further,
designed as a disposable device, the apparatus of Moore introduces
considerable cost.
[0006] An additional problem with Moore, and other devices which
introduce preformed panels or dressings, such as U.S. Pat. No.
5,409,472 to Rawlings, is that it is difficult or impossible to
cover the entire portion of the operating field that is bleeding,
while leaving the area of interest completely unobscured and
unobstructed.
[0007] The formation of scar tissue is a normal sequel to surgery
or other tissue injury and is required for proper wound healing. In
some cases, however, the scar tissue overgrows the intended region
and creates surgical adhesions. These scar tissue surgical
adhesions restrict the normal mobility and function of affected
body parts. Where peripheral nerves are involved, fibrous adhesions
can elicit severe pain during normal movement. Furthermore scars
and keloid tissue (raised scar tissue) are often unsightly and
present psychological and emotional problems.
[0008] Therefore there exists a need to not only reduce blood loss
during and after surgery, but also to reduce postoperative
adhesions. There are various approaches to reducing adhesions, but
none of them solve the problems described above with respect to
blood loss during surgery.
[0009] In particular, U.S. Pat. No. 5,711,958 to Cohn et al.,
incorporated by reference herein, discloses bioabsorbable polymeric
materials which were found to inhibit the formation of adhesions,
administered as rods, cylinders, foams, dispersions, viscous
solutions, liquid polymers, sprays or gels. An example provided
includes using a 10 mil thick film sutured into rabbits having
abraded intestines and removed muscle. There are no other examples
provided for using the other polymer forms mentioned, and there is
no suggestion as to how the film employed might be used to reduce
bleeding.
[0010] U.S. Pat. No. 6,607,512 to Oliver, et al, incorporated
herein by reference, discloses a device for delivering an
anti-adhesion gel during surgery, including applying a gel in both
endoscopic and open incision procedures. The device disclosed
allows the surgeon to apply the gel as one would apply paint with a
paint brush, in an even layer.
[0011] In addition to formation in connection with abrasions, as
discussed with respect to Cohn, above, adhesions also form in
association with implants. This is addressed in U.S. Pat. No.
6,187,043 to Ledergerber, which discloses coating implants,
particularly breast implants, with filaments of expanded PTFE
(PTFEe). Woven PTFEe is attached to a fabric backing, which is used
to encapsulate the implant.
[0012] A variety of anti-adhesion compositions are known, and are
disclosed in the cited references, as well as in U.S. Pat. No.
6,869,938 to Schwartz et al. In Schwartz, such compositions are
incorporated into membranes, sponges, and microspheres. Schwartz
discloses that sponges can be useful for hemostasis, but provides
no further details as to how the sponges might be used. U.S. Pat.
No. 5,176,700 to Brown discloses a laparoscopic intra-abdominal
device for blunt manipulation of a sponge including direct
hemostasis pressure on small blood vessels.
[0013] Thus various approaches to the reduction of blood loss
during surgery are disclosed, including localized cooling, but they
obscure and obstruct the operating field. Various solutions to the
problems attendant to adhesion formation are disclosed, but they do
not incorporate a solution to blood loss during surgery. It is
therefore an object of the invention to provide an integrated
solution to the problems of blood loss and adhesion, while avoiding
the limitations of the prior art.
SUMMARY OF THE INVENTION
[0014] The present invention provides for the reduction of blood
loss during surgery, as well as the reduction in the formation of
postoperative adhesions. Other advantages are realizable in
connection with the apparatus and methods of the invention, as
further described below.
[0015] In accordance with one embodiment of the invention, a
surgical field is filled with a viscous substance, such as gelatin
or a polymeric solution, which serves to retard or block the
ingress of blood from surrounding tissue. The viscous substance may
be optically clear, or may introduce some optical distortion,
however some visualization of the surgical field remains, whereupon
surgery may take place through the viscous substance.
[0016] Alternatively the bulk of the viscous substance immediately
surrounding the area of interest may be removed, as by manipulation
and or irrigation, so that an unobscured field of view, and
unobstructed target area is realized. Gel at the periphery of the
field is left intact, to continue to retard entry of blood into the
operating field.
[0017] The aforedescribed process may be used in both endoscopic
and open incision procedures. In accordance with another embodiment
of the invention, the surgical field is sprayed with a cooling
solution to cool the surrounding tissue sufficiently to achieve
vasoconstriction, and thus reduce blood flow temporarily while the
viscous substance is being applied. Depending upon the material
used, the viscous substance may additionally be treated with heat,
as by UV, RF, or warm air, or cooled, as by cool spray or cool air,
in order to be cured or hardened and made more durable.
Postoperatively, a heat cured or cold set dressing may be formed as
described above, providing good support to healing tissue, and
protection from infection.
[0018] The viscous substance may, in accordance with the invention,
be formed to contain agents which aid healing or provide other
therapeutic benefit, particularly substances which reduce the
incidence of the formation of adhesions, which are discussed in
greater detail below. Additional agents include blood clotting
agents, non-steroidal anti-inflammatories, steroidal agents,
analgesics, morphine, lidocaine, other anesthetics, calcium,
thrombin, hyaluronic acid, and epinephrine.
[0019] In accordance with a further embodiment of the invention,
the introduction of a viscous substance produces a distinct
advantage when working with surgical adhesives and cements, such as
bone cement. When cement is applied, it is common for a quantity of
cement to escape into surrounding tissue. Removal of this cement
can be a time consuming process, and introduces additional risk,
particularly during kyphoplasty and other work proximate delicate
tissue. When the surrounding tissue is coated with a viscous
substance, particularly gelatin or lubricants, the removal of
cement is greatly facilitated.
[0020] As described above, the immediate surgical field may be
cooled to promote vasoconstriction, and thus reduce blood flow and
blood loss. In accordance with the invention, all or a portion of a
limb may be partially or completely surrounded by a cuff which is
operative to squeeze the limb, and thus act as a tourniquet, while
simultaneously cooling blood flowing into the limb. Accordingly,
the degree to which the limb must be squeezed may be reduced when
combined with cooling, and thus the trauma to muscle tissue is
thereby reduced. The cuff is supplied with cold or hot air or
liquid, so that the temperature may be adjusted by either a
computer or the surgical practitioner during surgery. Temperature
control in this manner is particularly useful for limb salvage
surgery. The foregoing apparatus and method may advantageously be
combined with epinephrine, marcaine, or other vasoconstrictive
agent.
[0021] In accordance with another embodiment of the invention, a
balloon is placed within a surgical field, operative to apply
pressure to bleeding tissue. The balloon is inflated either before
or after placement. Where the balloon is inserted before inflation,
inflation pressure is advantageously used to distract, retract, or
otherwise displace tissue. The balloon may be sized to span the
entire surgical field, whereby pressure is applied to at least two
sides of the field. Alternatively, the balloon may be wedged
between tissue within the field, such as bone or soft tissue, and
the bleeding tissue. Multiple balloons may be used.
[0022] In another embodiment of the invention, the balloon is
caused to harden after inflation, whereupon portions of the balloon
which are not engaged with bleeding tissue, and which are not
needed for support, are excised. Where it is desired to leave the
remaining balloon portion within the body for a period of time, the
balloon may advantageously be fabricated with a biodegradable
material. Hardening is accomplished by coating the balloon with a
gel or polymer, as described above, which is set or cured by
cooling or heating. In this manner, the gel or polymer is disposed
proximate the bleeding tissue, and imparts the blood loss reduction
benefits described above.
[0023] In one embodiment, heating elements are disposed on or
within the balloon. Alternatively, heat or cold is created by
disposing chemical heat or cold pack units within the balloon.
Packs designed to generate heat or cold upon snapping or breaking a
barrier between separated chemical components, as known in the art,
are conveniently deployed within the balloon for this purpose.
Balloons may additionally be provided with channels for conducting
hot or cold liquids or gases.
[0024] Additionally, the balloons may be inflated and deflated
during the surgical procedure, in order to gain access to different
areas of the surgical field, or to restore compression to bleeding
tissue. The compressive force is adjusted by varying the internal
balloon pressure, or the force with which the balloon is wedged
within the surgical field. In endoscopic procedures, balloons are
inserted in a deflated state, and inflated once positioned.
Advantageously, inflation pressure is only slightly higher than
capillary pressure, whereby any burden on contacted tissue is
minimized.
[0025] Balloons may be inflated with a gas or a liquid. Where the
balloon is to be cut open, or is vulnerable to being pierced or
broken, a biocompatible material, such as filtered air or sterile
water, is of benefit.
[0026] In accordance with a further embodiment of the invention,
retractors and other tools used within the surgical field are
advantageously heated or cooled. As tools are commonly fabricated
using metal, such tools may be heated or cooled prior to use.
Alternatively, tools in accordance with the invention, having
channels for the conduction of heated or cooled liquid or gas are
advantageously deployed. Cooled tools contribute to
vasoconstriction, and may additionally be coated with gelatin or
polymer gels, with attendant benefits, as described above.
[0027] As described for tools, above, an implant may similarly be
heated or cooled, as well as coated with gelatin or gels, as
described above. Implants are similarly advantageously provided
with channels for cooling or heating. In addition, implants are
provided with means for generating heat once an implant is secured
and sealed within the body. In this manner, postoperative pain is
reduced, and healing accelerated. Heating may be accomplished by
dielectric or induction heating, or other means not requiring an
electrical connection.
[0028] A medical implant in accordance with the invention can be
fabricated, for example, with biodegradable polymers, cellular
based materials, or other biodegradable material. The implant may
additionally include a plurality of layers, each including biologic
agents as described herein. Each of the multiple layers may contain
the same biological agent, or medicinal agents. A treatment
protocol may require that different dosages of the medicinal agent
or different composition of the medicinal agent be released at
different times during the treatment protocol, an immediate release
vs. a delayed/retarded release. Microcapsules containing the agent
or medicament are additionally contemplated, either forming one or
more layers, or forming the entire implant. Implants advantageously
include bone spacers or other bone implants, where the formation of
adhesions can be particularly problematic.
[0029] In accordance with another embodiment of the invention, the
devices and methods described above may be combined with increasing
the atmospheric pressure in the operating room, in the patient, or
within the surgical field, thereby further reducing blood loss.
[0030] In accordance with yet another embodiment of the invention,
a combination of therapeutic substances may be administered to the
patient, cooperative with the devices and methods of the invention,
to increase the overall efficacy of the procedure. These may be
delivered before or after surgery, and may be timed release.
Additionally, any implanted device, e.g. balloon or other implant,
in accordance with the invention, may be formulated to be drug
eluting, either through incorporation into the gelatin or gel
matrix which coats the device, as described above, or by
formulating the device to contain therapeutic substances which are
released by known means, including biodegradation.
[0031] In accordance with a further embodiment of the invention,
system or local pH is made more alkaline, in order to decrease the
caustic effect of bleeding, thus protecting soft tissue and
decreasing pain.
[0032] As discussed above, itis an object of the invention to
reduce the formation of adhesions through introducing into the
surgical field a biologic agent, to inhibit scar formation, in
particular, surgical adhesions and exogenous bone formation. The
biologic agent is biodegradable and is thus reabsorbed over a
period of time. The biologic agent can be used to prevent or
inhibit the formation of adhesions in an animal following any type
of surgery or trauma, by applying an effective amount of the
biologic agent to a wound site, through incorporation into a
gelatin or gel matrix, applied directly or to an implant, or
through incorporation into an implant, as described above.
[0033] The wound site refers to a site of tissue that has been
injured in any manner, e.g., through surgery, contusion, abrasion
and so forth, and also refers to tissue or organs that are adjacent
to the injured tissue. For example, the biologic agent may be used
to prevent or inhibit adhesions that form in relation to intestinal
surgery, e.g., bowel resection, hernia repair, etc., which may
cause obstruction of the intestine. The biologic agent may also
prevent or inhibit adhesions or exogenous bone formation that can
form near a bone fracture site, joint repair or replacement site,
the formation of which may reduce or hinder the normal movement of
the area of repair by restricting the natural movement of tendons
over adjacent bone.
[0034] To aid in healing, the composition can additionally include
a medicinal agent. Exemplary medicinal agents include drugs,
enzymes, proteins, hormones, peptides, glycoproteins, or diagnostic
agents such as releasable dyes which may have no biological
activity per se.
[0035] Examples of classes of medicinal agents that can be used
include antimicrobials, analgesics, antipyretics, anesthetics,
antiepileptics, antihistamines, anti-inflammatories, anti-clotting
agents, bone morphogenic proteins, cardiovascular drug, diagnostic
agents, sympathomimetics, cholinomimetics, anti-muscarinics,
antispasmodics, hormones, growth factors, muscle relaxants,
adrenergic neuron blocks, anti-neoplastics, immunosuppressants,
gastrointestinal drugs, diuretics, steroids and enzymes. It is also
intended that combinations of medicinal agents can be used.
[0036] In addition to or as an alternative to, the medicinal agent
may be a therapeutic agent. Examples of such agents include, but
are not limited to, hormones, cells, fetal cells, stem cells, bone
morphogenic proteins (BMPs), enzymes, proteins, RNA, germicides,
gene therapy substances, cell therapy substances, viruses, etc.
[0037] In an embodiment the biologic agent is synovial fluid. The
synovial fluid can be harvested from the patient prior to or during
the surgical procedure by known techniques. Alternatively, the
synovial fluid can be harvested from a donor.
[0038] Alternatively, the biologic agent is cerebrospinal fluid.
The cerebrospinal fluid can be harvested from the patient prior to
or during the procedure by known techniques. Alternatively, the
cerebrospinal fluid can be harvested from a donor.
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] A more complete understanding of the present disclosure, and
the attendant advantages and features thereof, will be more readily
understood by reference to the following detailed description when
considered in conjunction with the accompanying drawings
wherein:
[0040] FIG. 1 is an illustration of an embodiment of the present
disclosure, for example an operating field including anatomical
elements of a body.
[0041] FIG. 2 is an additional illustration of an embodiment of
FIG. 1, for example, including a substance in the operating
field.
[0042] FIG. 2A is an additional illustration of an embodiment of
FIG. 1, for example, including a substance positioned with respect
to a blood vessel.
[0043] FIG. 3 is an additional illustration of an embodiment of
FIG. 1, for example, after a portion of the substance has been
removed.
[0044] FIG. 4 is an illustration of an embodiment of the present
disclosure, for example, including an endoscopic procedure.
[0045] FIG. 5 is an additional illustration of an embodiment of
FIG. 1, for example, including a spray.
[0046] FIG. 6 is an illustration of an embodiment of the present
disclosure, for example, including a dressing.
[0047] FIG. 7 is an illustration of an embodiment of the present
disclosure, for example, including adhesives and/or cement.
[0048] FIG. 8 is an illustration of an embodiment of the present
disclosure, for example, including a cuff.
[0049] FIG. 9 is an illustration of an embodiment of the present
disclosure, for example, including a balloon.
[0050] FIG. 10 is an additional illustration of an embodiment of
FIG. 9.
[0051] FIG. 11 is an illustration of an embodiment of the present
disclosure, for example, including a balloon positionable between
tissues.
[0052] FIG. 12 is an additional illustration of the embodiments of
FIG. 11.
[0053] FIG. 13 is an illustration of an embodiment of the present
disclosure, for example, including a balloon with heating
elements.
[0054] FIG. 14 is an illustration of an embodiment of the present
disclosure, for example, including a balloon with a heat or cold
pack and/or a component.
[0055] FIG. 15 is an illustration of an embodiment of the present
disclosure, for example, including a balloon with a channel and/or
an inlet.
[0056] FIG. 16 is an illustration of an embodiment of the present
disclosure, for example, including a tool.
[0057] FIG. 17 is an illustration of an embodiment of the present
disclosure, for example, including an implant.
[0058] FIG. 18 is an illustration of an embodiment of the present
disclosure, for example, including an implant with an inlet,
outlet, and/or channel.
[0059] FIG. 19 is an illustration of an embodiment of the present
disclosure, for example, including an implant with a heating
element.
[0060] FIG. 20 is an illustration of an embodiment of the present
disclosure, for example, including a spinal procedure.
[0061] FIG. 21 is an illustration of an embodiment of the present
disclosure, for example, an implant including micro capsules.
[0062] FIG. 22 is an additional illustration of an embodiment of
FIG. 21.
[0063] FIG. 23 is an illustration of an embodiment of the present
disclosure, for example, an implant including a spacer and/or
sponge.
[0064] Specific features of various embodiments may be shown in
some drawings and not in others, but this is for convenience only.
Any feature in any drawing may be referenced and/or claimed in
combination with any feature of any other drawing.
DETAILED DESCRIPTION OF THE INVENTION
[0065] Referring now to the figures, in which like reference
numerals refer to like elements, FIG. 1 illustrates a surgical
operating field 10, in this illustration in the neck 12 of a
patient, however in accordance with the invention, the surgical
field could be anywhere in the body. Retractors 14a-d contact cut
skin tissue 16, and maintain tissue 16 apart, creating operating
field 10. As a result, an area of surgical interest 18 is created,
containing one or more anatomical elements 20a-b upon which a
surgical procedure is to be carried out.
[0066] With reference now to FIG. 2, in accordance with the
invention, a surgical field is filled with a viscous substance 22,
illustrated by boundary line 24, hatched reflection lines 26, and
the blurring or optically less clear view of operating field 10.
Viscous substance 22 includes a gelatin or a polymeric solution,
which serves to retard or block the ingress of blood from blood
vessels in cut skin tissue 16 and other tissue 24 within the
surgical field, which may also contain cut tissue and blood
vessels. With reference to FIG. 2a, viscous substance 22 surrounds
and adheres to the cut ends 16a of cut blood vessels 16b. The
viscous substance may be optically clear, or may introduce some
optical distortion as shown in FIG. 2, however some visualization
of the surgical field remains, whereupon surgery may take place
through viscous substance 22, as by inserting the surgeons hands
(not shown) or surgical tools into viscous substance 22, as can be
seen in the prongs of retractors 14a-d, and as can be seen in FIG.
4, discussed below.
[0067] Alternatively a portion, in some cases the majority of
viscous substance 22 immediately surrounding the area of interest
18 may be removed, as by manipulation and/or irrigation, so that an
unobscured field of view, and an unobstructed target area are
realized. In FIG. 3, boundary line 24 indicates an exterior
boundary, and after a portion of viscous substance 22 has been
removed, inner boundary line 28 indicates an interior boundary.
Viscous substance 22, for example gelatin or polymeric gel, at the
periphery of field 10 is left intact, particularly viscous
substance 22 which is in direct contact with cut tissues 16,24,
whereby viscous substance 22 may continue to retard entry of blood
into operating field 10.
[0068] Viscosity of viscous substance 22 is advantageously in a
range whereby the substance will effectively adhere to bodily
tissue, without running off or dispersing during the surgical
procedure, or at least, not having to be reapplied repeatedly. This
represents a centipoise or cP value of at least 25. A viscosity
that is too high will impose difficulties in spreading the
substance on body tissue without imposing too much pressure on the
tissue, typically not higher than 2,500. Values in the range of 200
to 1500 cP are advantageously employed for most body tissue. It
should be understood that these values are provided as
illustrative, and that features of the viscous substance as
described, that is of not dispersing too quickly, or imposing too
much difficulty in spreading, determine ideal viscosity for the
viscous substance, based on the body tissue and application, as
best determined by the surgical practitioner.
[0069] Viscous substance may be any of a wide variety of substances
with the desired viscosity and biocompatibility, including gelatin,
gel polymers, biocompatible lubricants, water based lubricants,
silicone based lubricants, viscous degradeable polymers, and other
materials described herein.
[0070] With reference to FIG. 4, the aforedescribed process in
accordance with the invention may be used in both endoscopic (FIG.
4) and open incision (FIGS. 1-3) procedures. In FIG. 4, trocar
introduces carbon dioxide gas into abdomen 32, facilitating the
introduction and manipulation of endoscopic instruments, here
laparoscopic tools 34, 36. In accordance with the invention,
viscous substance 22 is placed around surgical tools 30, 34, 36 at
the point of entry into abdomen 32, where skin has been cut or
pierced. As the tools are inserted into the body, viscous substance
22 is driven downwards through cut skin 16 into the body, by a
spreading force imparted by the surface of tools 30, 34, 36,
whereby cut blood vessels inside the incision or piercing are
coated with viscous substance 22 to attain the benefits as
described herein. In addition, an endoscopic tool, such as tool 36,
may be used to introduce viscous substance into the interior of the
body, whereby it may be injected, pumped, sprayed, or brushed into
contact with cut, damaged or disturbed tissue 16a. In the example
shown, viscous substance 22 covers a portion of operating field 10,
and the entire area of interest 18, whereby the working ends 34a,
36a of tools 34, 36 are beneath the surface of viscous substance
and completely enveloped within viscous substance 22. In this
manner, while there may some loss of visual clarity, the loss is
offset by having the area of interest 18 substantially less
obfuscated by blood.
[0071] With reference to FIG. 5, in accordance with a further
embodiment of the invention, surgical field 10 is sprayed with a
cooling substance 38 to cool operating field 10 and cut tissue 16
sufficiently to achieve vasoconstriction, and thus reduce blood
flow temporarily while the viscous substance is being applied.
Cooling substance 38 may additionally be applied adjacent to the
operating field, to promote vasoconstriction in surrounding
tissues, and thus reduce blood flow in surgical field 10. In the
example shown, a spray can 40 is illustrated, whereby substance 38
cools as it leaves can 40, due to a change of pressure.
Alternatively, can 40 may be chilled prior to use. While a spray
can is illustrated, it should be understood that any means of
spraying is contemplated by the invention, including separate
pumps, reservoirs and sprayer nozzles (not shown). Cooling
substance 38 includes sterile air or water, or other substance
which is biocompatible. In addition, in accordance with the
invention, cooling substance may advantageously comprise viscous
substance 22, although a more robust sprayer than a spray can would
typically be required. Cooling substance 38 may additionally
incorporate a vasoconstrictive biologic agent, such as but not
limited to adenosine triphosphate, amphetamines, antihistamines,
catecholamines, endothelin, ergine, methylphenidate, neuropeptide
Y, norepinephrine, phenylephrine, pseudoephedrine, epinephrine,
marcaine or thromboxane.
[0072] Depending upon the material used, viscous substance 22 may
additionally be treated with heat, as by warm air, or cooled, as by
cool spray or cool air, or alternative exposed to UV light, in
order to be cured or hardened, made more durable, and caused to
adhere with greater strength to cut blood vessels in cut
tissue.
[0073] With reference to FIG. 6, in a further embodiment of the
invention, a dressing 42, formed with UV, heat or cold setting
viscous substance 22 is applied postoperatively to a surgical
closure 44, providing good support to healing tissue through
adhesion, and protection from infection by forming a closely
conforming barrier that is impermeable to microorganisms.
[0074] The viscous substance may be formed to contain agents which
aid healing or provide other therapeutic benefit, particularly
substances which reduce the incidence of the formation of
adhesions, which are discussed in greater detail below. Additional
agents include blood clotting agents, non-steroidal
anti-inflammatories, steroidal agents, analgesics, morphine,
lidocaine, other anesthetics, calcium, thrombin, hyaluronic acid,
and epinephrine, and other therapeutic agents described herein.
[0075] With reference to FIG. 7, in accordance with another
embodiment of the invention, the introduction of a viscous
substance produces a distinct advantage when working with surgical
adhesives and cement 46, such as bone cement. When cement 46 is
applied, as by applicator 48, it is common for a quantity of cement
46a, 46b to escape into surrounding tissue. Removal of this cement
can be a time consuming process, and introduces additional risk,
particularly during kyphoplasty (illustrated) and other work
proximate delicate tissue. When the surrounding tissue is coated
with viscous substance 22, particularly gelatin or lubricants, the
removal of cement is greatly facilitated. In the example depicted,
cement 46b has fallen directly onto bone 50, whereupon tools (not
shown) and considerable force must be applied for removal. Should
the surgical practitioner slip, grave injury may result. In
contrast, cement 46a has fallen upon a substrate of viscous
substance 22, and because viscous substance 22 is easily sheared,
the hardened cement 46a is easily removed with greatly reduced risk
to the patient
[0076] As described above, the immediate surgical field may be
cooled to promote vasoconstriction, and thus reduce blood flow and
blood loss. In accordance with the invention, as shown in FIG. 8,
all or a portion of a limb 52 may be partially or completely
surrounded by cuff 54 which is operative to squeeze the limb, and
thus act as a tourniquet, while simultaneously cooling blood
flowing into the limb. In the embodiment shown, cool gas or liquid,
such as air or water, passes from a chiller (not shown) through
inlet hose 56, through inlet 56a communicative with internal
channel 60, through internal channel 60 to outlet 58a, thence
through outlet hose 58 either to be recirculated or exhausted.
Postoperatively, or as the surgeon deems beneficial, warmed gas or
liquid may be passed through cuff 54 for therapeutic benefit, or
for the comfort of the patient.
[0077] The device of FIG. 8 presents the surgeon with the
opportunity to reduce the degree to which the limb must be
squeezed, as the limb now additionally experiences vasoconstriction
as a result of the cooling of blood vessels. Thus the trauma to
muscle tissue through the physical crushing pressure and localized
loss of blood flow imposed by tourniquet action is reduced.
[0078] The temperature of gas or liquid flowing through the cuff
may be adjusted by either a mechanical or computer interface, or by
the surgical practitioner during surgery. Temperature control in
this manner is particularly useful for limb salvage surgery. The
foregoing apparatus and method may advantageously be combined with
epinephrine, marcain, or any of the other vasoconstrictive agents
mentioned herein.
[0079] In accordance with another embodiment of the invention, and
with reference to FIGS. 9 and 10, a balloon 62 is placed within
surgical field 10, operative to apply pressure to bleeding tissue.
Balloon 62 is formed of any biocompatible elastomeric polymer, such
as rubber, latex, and synthetic rubber compounds. Balloon 62 is
inflated either before or after placement within the surgical
field. Where the balloon is inserted before inflation, inflation
pressure is advantageously used to distract, retract, or otherwise
displace tissue. In the example illustrated, cut skin 16 and other
bodily tissue is pressed, for example at region of greatest
pressure 64. The balloon may be sized to span the entire surgical
field, whereby pressure is applied to at least two sides of the
field, as is illustrated in FIG. 9. Alternatively, as shown in FIG.
11, balloon 80 may be wedged between tissue within the field, such
as bone 82 or soft tissue, and bleeding tissue 16, 24. In addition,
multiple balloons may be used.
[0080] In another embodiment of the invention, and with particular
reference to FIG. 10, balloon 62 is caused to harden after
inflation, whereupon portions of the balloon which are not engaged
with bleeding tissue 16, 24, and which are not needed for support,
are excised. In the illustration, a portion represented by oval 66
has been removed from the exterior portion of the balloon, after
which, a portion illustrated by oval 68 is removed, whereby the
surgical area of interest 18 is revealed, exposing anatomical
elements 20c-e. Where it is desired to leave the remaining balloon
portion within the body for a period of time, balloon 60 may
advantageously be fabricated with a biodegradable material.
Hardening is accomplished by coating the balloon with viscous
substance 22, such as a gelatin or gel polymer, which is set or
cured by cooling, heating, or exposure to UV light, as described
herein. In this manner, viscous substance 22 is disposed proximate
the bleeding tissue, and imparts the blood loss reduction benefits,
and other therapeutic benefits, described herein.
[0081] Referring now to FIGS. 11 and 12, as described above,
balloon 80 is sized and shaped to advantageously fit in a part of
the space within surgical field 10. In the example shown, the
balloon is pressed between trochlear groove 84 of femur 86 and cut
tissue 16, obscuring a portion of trochlear groove 84. Upon
hardening, a portion of balloon 80 is cut at 88 to expose an
additional area of trochlear groove 84. Balloon 80 remains in
position against cut tissue 16 through adhesion of viscous
substance 22 to cut tissue 16, 24, as well as by support from
remaining hardened balloon portion 90.
[0082] With reference to FIG. 13, in one embodiment, heating
elements 92 are disposed on or within balloon 94. Elements 92 may
comprise metallic or ferrous material that is heated by
radiofrequency energy (RF) during and or after surgery to produce
heat by induction. Alternatively, elements 92 may be connected to a
source of electricity, particularly during surgery, and caused to
generate heat through electrical resistance or other known
means.
[0083] Alternatively, heat or cold is created by disposing chemical
heat or cold packs 96 within balloon 98. Packs 96 designed to
generate heat or cold upon snapping or breaking a barrier or
enclosed container 100 between separated chemical components, such
as components 102, 104, as known in the art, are conveniently
deployed within the balloon for this purpose. To produce cold, an
endothermic reaction takes place between chemical components 102,
104, and an exothermic reaction between components 102, 104
produces heat. Balloon 98 may be filled with a liquid or gas,
including water or air, selected for its ability to transmit the
temperature change produced by pack 96 to the surface 106 of the
balloon, and to generate an even temperature on the surface 106 of
balloon 98.
[0084] Similarly, component 102 may be contained within balloon 98,
itself as opposed to pack 96. In this manner, container 100 is
disposed within balloon 98, and is broken to produce the
temperature change reaction. Container 100 may alternatively be
replaced by a wall or other barrier formed within balloon 98.
Further, component 104 may be injected into a balloon 98 which
contains component 102; in an amount calculated to produce the
appropriate amount of temperature change.
[0085] In accordance with another embodiment of the invention, as
can be seen in FIG. 15, balloons 110 are provided with at least one
channel 112 for conducting hot or cold flowable materials, such as
liquids or gases. Flowable material of desired temperature enters
inlet 114, and passes through channel 112, changing the temperature
of the surface of balloon 110, and eventually exiting at outlet
116. Flowable material exiting outlet 116 may be discarded, or may
be recirculated, as known in the art.
[0086] Additionally, balloons in accordance with the invention,
including balloons 62, 80, 94, 98, 110 may be inflated and deflated
during the surgical procedure, as by passage of a liquid or a gas
through a valve 108, in order to gain access to different areas of
surgical field 10, or to restore compression to bleeding tissue 16,
24. The compressive force is adjusted by varying the internal
balloon pressure, or the force with which the balloon is wedged
within the surgical field. In endoscopic procedures, balloons are
inserted in a deflated state, as by passage through tool 30 or 36,
and inflated once positioned. Advantageously, inflation pressure is
only slightly higher than capillary pressure, whereby any burden on
contacted tissue is minimized.
[0087] Balloons may be inflated with a gas or a liquid. Where the
balloon is to be cut open, or is vulnerable to being pierced or
broken, a biocompatible material, such as filtered air or sterile
water, is of benefit.
[0088] In accordance with a further embodiment of the invention,
and with reference to FIG. 16, retractor 120 and other tools used
within the surgical field are advantageously heated or cooled. As
tools are commonly fabricated using metal, such tools may be heated
or cooled prior to use. Alternatively, tools in accordance with the
invention, for example retractor 120 having a channel 122 for the
conduction of heated or cooled flowable material, such as a liquid
or gas, are advantageously deployed. Cooled tools contribute to
vasoconstriction, and may additionally be coated with gelatin or
polymer gels, with attendant benefits, as described above. Tools in
accordance with the invention may additionally be heated by RF
radiation or heating elements, as described with respect to
balloons 94, 98 of FIGS. 13 and 14.
[0089] In the example shown in FIG. 16, flowable material enters
inlet 124, and travels through channel 122, adjusting the
temperature of retractor 120, including tissue contacting portion
128 by conduction, eventually exiting at outlet 126.
[0090] As described for balloons and tools, above, an implant may
similarly be heated or cooled, as well as coated with viscous
substance 22, as described above. With reference to FIG. 17,
implant 130, in this example a knee implant to be attached to
resected femur 132, is coated with viscous substance 22. In
accordance with the invention, the formation of postoperative
adhesions is reduced due to the viscosity of viscous substance 22,
and to its role as a barrier between disturbed or damaged tissue.
Further, a substance known to reduce the formation of adhesions,
including synovial fluid, cerebrospinal fluid, hyaluronic acid, or
other materials described herein, is admixed into viscous substance
22, whereby a dual or synergistic substance anti-adhesion effect is
obtained.
[0091] With reference to FIG. 18, implant 134 is advantageously
provided with an inlet 136, outlet 138, and channel 140 for cooling
or heating, as described herein. In addition, intramedullary rod
142 connected to implant 134 includes a segment of channel 140 (not
shown), whereby temperature adjusted flowable material,
advantageously cooled material, passes down the interior of
intramedullary rod 142, thus cooling the interior of femur 132, and
thereby reducing blood loss through vasoconstriction, and/or
increasing the viscosity of blood through cooling.
[0092] In addition, with reference to FIG. 19, implant 144 is
provided with heating element 146, controllable during surgery, or
operative once an implant is secured and scaled within the body.
After surgery, heat is advantageously introduced to reduce
postoperative pain, and to accelerate healing. Heating may be
accomplished by dielectric or induction heating, or other means not
requiring an electrical connection, as described herein.
[0093] With reference to FIG. 20, a spinal implant 148 is implanted
within disc space 150. Implant 148 may be provided with heating and
cooling as described elsewhere herein for implants. In addition,
implant 148 may be coated with viscous substance 22, as described
above, to provide the therapeutic benefits described herein.
Viscous substance 22 is additionally applied to cover a portion of
implant 148 exposed to overlying tissue (not shown), which may have
been damaged or disturbed during surgery. Further, tissue adjacent
the implant has been damaged or disturbed. It has been found that
adhesion formation is particularly a problem where separate tissue
areas which have been disturbed or damaged, as by being abraded or
cut, come into contact during healing, wherein adhesions form
between the separate tissue areas. In accordance with the
invention, viscous substance 22 interposed between separate tissue
areas, reduces the formation of adhesions.
[0094] A medical implant in accordance with the invention can be
fabricated, for example, with biodegradable polymers, cellular
based materials, or other biodegradable material. The implant may
additionally include a plurality of layers, each including biologic
agents as described herein. Each of the multiple layers may contain
the same biological agent, or medicinal agents. A treatment
protocol may require that different dosages of the medicinal agent
or different composition of the medicinal agent be released at
different times during the treatment protocol, an immediate release
vs. a delayed/retarded release. Microcapsules containing the agent
or medicament are additionally contemplated, either forming one or
more layers, or forming the entire implant. Implants advantageously
include bone spacers or other bone implants, where the formation of
adhesions can be particularly problematic. The implant can
additionally be located in any other joint of the body not
discussed herein, including the foot, ankle, hip, shoulder, elbow,
wrist and hand.
[0095] In accordance with another embodiment of the invention, the
devices and methods described above may be combined with increasing
the atmospheric pressure in the operating room, in the patient, or
within the surgical field, thereby further reducing blood loss.
[0096] In yet another embodiment of the invention, the various
coatings of viscous substance 22 are electrically charged to cause
vasoconstriction, and/or to create a diffuse cauterization of the
bleeding portions 16, 24 of the surgical field 10.
[0097] In a further embodiment of the invention, blood clotting or
coagulation products are admixed into the coating of viscous
substance 22, whereby the viscous substance effectively maintains
the products in close conformity to the cut ends 16a of cut blood
vessels 16b.
[0098] In accordance with yet another embodiment of the invention,
a combination of therapeutic substances may be administered to the
patient, cooperative with the devices and methods of the invention,
to increase the overall efficacy of the procedure. These may be
delivered before or after surgery, and may be timed release.
Additionally, any implanted device, balloon or other implant, in
accordance with the invention, may be formulated to be drug
eluting, either through incorporation into the gelatin or gel
matrix which coats the device, as described above, or by
formulating the device to contain therapeutic substances which are
released by known means, including biodegradation.
[0099] In accordance with a further embodiment of the invention,
system or local pH is made more alkaline, in order to decrease the
caustic effect of bleeding, thus protecting soft tissue and
decreasing pain.
[0100] As discussed briefly above, and will be more particularly
described below, the present invention provides a method of using a
biologic agent to inhibit scar formation, in particular, surgical
adhesions and exogenous bone formation. The biologic agent is
biodegradable and is thus reabsorbed over a period of time. The
biologic agent can be used to prevent or inhibit the formation of
adhesions in an animal following any type of surgery or trauma, by
applying an effective amount of the biologic agent to a wound
site.
[0101] The wound site refers to a site of tissue that has been
injured in any manner, e.g., through surgery, contusion, abrasion,
and so forth, and also refers to tissues or organs that arc
adjacent to the injured tissue. For example, the biologic agent may
be used to prevent or inhibit adhesions that form in relation to
intestinal surgery, e.g., bowel resection, hernia repair, etc.,
which may cause obstruction of the intestine. The biologic agent
may also prevent or inhibit adhesions or exogenous bone formation
that can form near a bone fracture site, joint repair or
replacement site, the formation of which may reduce or hinder the
normal movement of the area of repair by restricting the natural
movement of tendons over adjacent bone.
[0102] The biologic agent may be included with a composition within
a carrier material, e.g., water, gel, or a nonaqueous solvent. To
aid in healing, the composition can additionally include a
medicinal agent. Exemplary medicinal agents include drugs, enzymes,
proteins, hormones, peptides, glycoproteins, or diagnostic agents
such as releasable dyes which may have no biological activity per
se.
[0103] Examples of classes of medicinal agents that can be used
include antimicrobials, analgesics, antipyretics, anesthetics,
antiepileptics, antihistamines, anti-inflammatories, anti-clotting
agents, bone morphogenic proteins, cardiovascular drug, diagnostic
agents, sympathomimetics, cholinomimetics, anti-muscarinics,
antispasmodics, hormones, growth factors, muscle relaxants,
adrenergic neuron blocks, anti-neoplastics, immunosuppressants,
gastrointestinal drugs, diuretics, steroids and enzymes. Itis also
intended that combinations of medicinal agents can be used.
[0104] In addition to or as an alternative to, the medicinal agent
may be a therapeutic agent. Examples of such agents include, but
are not limited to, hormones, cells, fetal cells, stem cells, bone
morphogenic proteins (BMPs), enzymes, proteins, RNA, germicides,
gene therapy substances, cell therapy substances, viruses, etc.
[0105] In one embodiment of the invention, the biologic agent is
synovial fluid. The synovial fluid can be harvested from the
patient prior to or during the surgical procedure by known
techniques. Alternatively, the synovial fluid can be harvested from
a donor.
[0106] Alternatively, the biologic agent is cerebrospinal fluid.
The cerebrospinal fluid can be harvested from the patient prior or
during the procedure by known techniques. Alternatively, the
cerebrospinal fluid can be harvested from a donor.
[0107] Referring to FIG. 20, an exemplary surgical site or field 10
is provided. The surgical field 10 can be, as examples, intestinal,
cardiac, or joint sites. During and or after the surgical
procedure, the biologic agent 152 is applied to the surgical field
10 by any convenient mode 154, including admixed into viscous
substance 22 as described above.
[0108] Referring to FIG. 21, the biodegradable implant 156 may be
made up of a plurality of layers or sections 158, each including
the biologic agent 152. The biologic agent 152 is released as the
layers 158 of the biodegradable implant degrade. The degradation
rate of the biodegradable implant 156 can be controlled by the
ratio of PLA to PGA, or by the thickness or density of the layers
158, or interposed layers 160.
[0109] Each of the multiple layers may contain the same biological
agent 152 as well and a medicinal agent. The medicinal agents
(and/or the composition of the agents) in each of the multiple
layers may be the same or different. A treatment protocol may
require that different dosages of the medicinal agent or different
composition of the medicinal agent be released at different times
during the treatment protocol, an immediate release vs. a
delayed/retarded release. The multiple-layers, each containing
different dosages of the medicinal agents or different compositions
of the medicinal agents, allow for the controllable release of the
differing medicinal agents during the protocol.
[0110] Referring again to FIG. 21, the medical implant 156 includes
at least one layer of micro capsules 162. The biologic agent 152 is
contained within the micro capsule 162. The micro capsules 162 may
be bonded to the medical implant 156 with a biodegradable agent,
such that as the biodegradable agent degrades, micro capsules 162
are released. Similarly, the micro capsules 162 may be made of a
biodegradable material, such that as the micro capsules 162
degrade, the biologic agent 152 will be released.
[0111] Alternatively, as can be seen in FIG. 22, the medical
implant 164 may be made entirely of micro capsules 162 bonded
together. The bonded microcapsule 162 can be appropriately shaped
and sized depending on the intended area of use. The micro capsules
162 may be bonded together with a biodegradable agent, such that as
the biodegradable agent degrades the micro capsules 162 are
released. Similarly, the micro capsules 162 may be made of a
biodegradable material, such that as the micro capsules 162 degrade
the biologic agent 152 will be released.
[0112] Referring to FIG. 23 the medical implant 166 is a spacer or
sponge. The biologic agent 152 is incorporated in the medical
implant 164, for insertion into the surgical site. The biologic
agent 152 seeps from the medical implant 164 to the surrounding
tissue. Additionally, the biologic agent 152 can be applied to the
surrounding tissue as described above.
[0113] The medical implant 166 can be a biodegradable implant. The
biodegradable implant 166 hydrophilically reacts to release the
biologic agent 152. The biodegradable implant 166 is made of a
biodegradable polymer, polyactic acid ("PLA"), polyglycolic acid
("PGA"), and copolymers thereof collagen, cellulose, fibrin,
autograft, allograft, or other cellular based compounds. The
biologic agent 152 may be affixed to the biodegradable implant by
coating, mixing, or bonding techniques.
[0114] Referring back to FIG. 20, in an alternative embodiment,
implant 148 is a joint spacer, for changing the spatial
relationship between first and second bones 168, 170, and
incorporates biologic agent 152 as described above. The medical
implant 148 includes a body configured and dimensioned for
insertion into a joint 150 located between the first and second
bones 168, 170. As discussed above the biologic agent 152 is
incorporated into or coated on the implant 148. The biological
agent 152 inhibits the formation of adhesion, scar tissue, or
exogenous bone that would limit the movement of the first and
second bones 168, 170, or that might otherwise cause pain or
discomfort. Additionally, the biologic agent 152 can be applied to
the surrounding tissue as described above.
[0115] Implant 148 can be a temporary spacer, left in position for
a set time period, upon expiration of which the implant 148 is
removed and/or replaced. For example, in younger patients, not
suitable candidates for spinal fusion, implant 148 is inserted
between the effected vertebrae, to stabilize the spinal area for a
period of time. At the expiration of the time period, patient is
evaluated. The implant 148 is then removed and, if required,
replaced.
[0116] Alternatively, the implant 148 is made of a biodegradable
material. The biologic agent 152 is incorporated in biodegradable
implant 148, for insertion in between the vertebrae. The biologic
agent 152 seeps from the biodegradable intervertebral spacer 22 to
the surrounding tissue. Additionally, the biologic agent 152 can be
applied to the surrounding tissue as described above.
[0117] In another embodiment in accordance with the invention,
implant 148 hydrophilically reacts to release the biologic agent
152. Implant 148 is made of a biodegradable polymer, polyactic acid
("PLA"), polyglycolic acid ("PGA") and copolymers thereof collagen,
cellulose, fibrin, autograph, allograph, or other cellular based
compounds. The biologic agent 152 may be affixed to the
biodegradable implant by coating, mixing, or bonding the biologic
agent to the biodegradable intervertebral spacer 22.
[0118] Referring again to FIG. 21, the implant 148 may be made of a
plurality of layers or sections 158, each including the biologic
agent 152. The biologic agent 152 is released as the layers 158 of
the biodegradable implant degrade. The degradation rate of the
biodegradable implant can be controlled by the ratio of PLA to PGA,
or by the thickness or density of the layers, as described
above.
[0119] All references cited herein are expressly incorporated by
reference in their entirety.
[0120] It will be appreciated by persons skilled in the art that
the present invention is not limited to what has been particularly
shown and described herein above. In addition, unless mention was
made above to the contrary, it should be noted that all of the
accompanying drawings are not to scale. A variety of modifications
and variations are possible in light of the above teachings without
departing from the scope and spirit of the invention.
* * * * *